Bausch + Lomb Receives FDA 510(k) Clearance for Bi-Blade+(TM) Dual-Port Vitrectomy Cutter and Adaptive Fluidics(TM) Advanced Update

• The U.S. Food and Drug Administration issued a 510(k) clearance for the Bi‑Blade+ dual‑port vitrectomy cutter and its accompanying Adaptive Fluidics software update on the Stellaris Elite Vision Enhancement System.
• Technical improvements: cutting speed ↑ to 25,000 cpm (vs 15,000 cpm), flow rate +≈25%, cutter vibration –62%, infusion pressure –62% with Adaptive Fluidics, and intra‑ocular pressure stability within 10‑20 mmHg.
• The clearance applies only to Bausch + Lomb’s Stellaris Elite platform equipped with the new procedure packs.

• Scope: A regulatory clearance for an incremental hardware/software upgrade. No new indication, no major market expansion, and the product is already in commercial use (Stellaris Elite).
• Market expectation: The clearance was anticipated; Bausch + Lomb had previously announced upcoming FDA filings for Bi‑Blade+. Hence the news confirms expectations rather than surprises.
• Revenue effect: Incremental sales uplift expected from existing Stellaris customers upgrading to Bi‑Blade+ packs and from new adopters attracted by performance gains. The impact is likely a modest double‑digit percentage increase in surgical device revenue on a low‑single‑digit absolute dollar basis (Surgical segment was $894 M FY2025).
• Risk: Limited to the product’s compatibility – only works with Stellaris Elite systems, capping addressable market. No change to royalty structure or pricing disclosed.

Conclusion: The announcement is a routine positive development; it validates the pipeline and may modestly boost short‑term surgical revenue but does not constitute a material catalyst.

Bausch + Lomb is a global leader in eye health, operating across three segments: Vision Care (contact lenses & OTC products), Surgical (intra‑ocular lenses, vitrectomy cutters, laser platforms), and Pharmaceuticals (dry‑eye, ocular inflammation).
Flagship surgical platform: Stellaris Elite Vision Enhancement System, now upgraded with Bi‑Blade+ cutter and Adaptive Fluidics.